OBERDORF SYNTHES PRODUKTIONS GMBH 4.5MM VA-LCP CURVED CONDYLAR PLATE/18HOLE/370MM/LT-STER; IMPLANT, FIXATION DEVICE, CONDYLAR PLATE
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Catalog Number 02.124.419S |
Device Problem
Crack (1135)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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Patient¿s weight is not available for reporting.Date of event: date of postoperative plate breakage is unknown.Additional device product cods: hrs, hwc.The subject device has been received and the product evaluation is in progress.No conclusion can be drawn.A review of the device history records has been requested and is currently pending completion.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Device report from synthes europe reports an event in (b)(6) as follows: it was reported that a patient was treated for a distal femoral fracture on (b)(6) 2018 and was implanted with variable angled -locking compression (va-lcp) condylar plate.At recent follow up a crack was noticed in the plate, propagating through one of the locking holes.Revision surgery was performed on (b)(6) 2018 and plate and screws were removed.There was surgical delay reported.Patient outcome is reported as unknown.Concomitant devices reported: 5.0 mm va locking 34mm (part # 02.231.234, lot # 8539474, quantity 3), 5.0 mm va locking 34mm (part # 02.231.234, lot # l648055, quantity 1), 5.0 mm va locking 34mm (part # 02.231.234, lot # l498943, quantity 1), 5.0 mm va locking 50mm (part # 02.231.250, lot # l482579, quantity 1), 5.0 mm va locking 75mm (part # 02.231.275, lot # l718822, quantity 1), 5.0 mm va locking 70mm (part # 02.231.270, lot # l499012, quantity 1), 5.0 mm va locking 80mm (part # 02.231.280, lot # l704215, quantity 1), 5.0 mm va locking 65mm (part # 02.231.265, lot # l362057, quantity 1), 4.5 mm cortex screw 30mm (part # 214.830, lot # unknown, quantity 1).This report is for one (1) va-lcp condylar plate 4.5/5.0 le 18ho l3.This is report 1 of 1 for complaint (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device history record (dhr) review: part: 02.124.419s; lot: l437237; manufacturing site: mezzovico; release to warehouse date: june 21, 2017; expiry date: june 01, 2027.The device history record shows this lot of 12 pieces was processed through the normal manufacturing and inspection operations with no rework or nonconformities noted.This lot met all dimensional and visual criteria at the time of release with no issues documented during the manufacturing process.Review of the device history record showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.H3, h6: investigation summary: investigation selection investigation site: mezzovico selected flow(s): 5.Broken visual inspection: the item referred in product investigation has been received not in original packaging.The plate is visually cracked post production at level of hole va2 and it¿s bent post-production in the breakage area.Information etched match to complaint system and dhr.No visual defects manufacturing related have been identified on returned item.Drawing/specification review: the returned item has been manufactured in june 2017 according to the drawing released on february 19th, 2016.No nonconformances or document change have been identified which may be related to the complaint condition.The manufacturing specification for material defined by drawing is: stainless steel (316l/1.4441).Dimensional inspection: the returned part was reinspected for all the features relevant to the complaint condition.All the measurable features (thickness, width and va holes features) have been found conforming to manufacturing specification.Material or hardness review: the involved lot l437237 has been manufactured starting from the raw material lot 20055.The certificate of raw material for lot 20055 has been reviewed: in the certificate it is reported that the material is conforming to specification.Summary: as per selected investigation flow from the investigation instruction guide, a visual inspection has been performed and it confirmed that the received condition agrees with the complaint condition but no visual defects manufacturing related have been identified on returned item.The dimensional re-inspection, the raw material certificate review and the document/specification review didn¿t identify any manufacturing defect or deficiency, thus the complaint investigation is considered as not manufacturing related.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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